Food and Drug Administration

USAU.S. FDAintroduce

The U.S. Food and Drug Administration (The FDA (or U.S. FDA) is a federal agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting and promoting the public health through the control and regulation of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter drugs (pharmaceuticals), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (EREDs), cosmetics, animal food and feed, and veterinary products.

The FDA's primary responsibility is to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act). The agency also administers other laws, particularly Section 361 of the Public Health Service Act and related regulations. Much of its regulatory and enforcement work does not directly involve food or drugs, including oversight of lasers, cell phones, and condoms. Furthermore, the FDA is responsible for disease control in areas ranging from household pets to human sperm used in assisted reproduction.

The FDA is led by a Commissioner of Food and Drugs, who is appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. As of January 24, 2025, Sara Brenner serves as Acting Commissioner, succeeding Commissioner Robert Califf, who resigned on January 20, 2025.

The FDA is headquartered in White Oak, Silver Spring, Maryland. The agency operates 223 field offices and 13 laboratories across all 50 states, the Virgin Islands, and Puerto Rico. Since 2008, the FDA has deployed personnel to countries such as China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

Organizational Structure

Department of Health and Human Services

Food and Drug Administration

Director's Office (C)

Office of the Legal Counsel (OCC)

Executive Secretariat (OES)

Office of the Director's Advisor

Office of Digital Transformation (ODT)

Center for Biologics Evaluation and Research (CBER)

Center for Devices and Radiological Health (CDRH)

Center for Drug Evaluation and Research (CDER)

Center for Food Safety and Applied Nutrition (CFSAN)

Center for Tobacco Products (CTP)

Center for Veterinary Medicine (CVM)

Oncology Center of Excellence (OCE)

Office of Regulatory Affairs (ORA)

Office of Clinical Policy and Programs (OCPP)

Office of External Affairs (OEA)

Office of Food Policy and Response (OFPR)

Office of Minority Health and Health Equity (OMHHE)

Operations Office (OO)

Office of Policy, Legislation and International Affairs (OPLIA)

Office of the Chief Scientist (OCS)

National Center for Toxicology Research (NCTR)

Office of Women's Health (OWH)

Location

Headquarters

FDA headquarters facilities are currently located in Montgomery County and Prince George's County, Maryland.

White Oak Federal Research Center

sinceSince 1990, the FDA has maintained staff and facilities at the White Oak Federal Research Center in Silver Spring, Maryland, occupying 130 acres (53 hectares). In 2001, the General Services Administration (GSA) began construction on the campus, aiming to consolidate FDA's 25 operations in the Washington, D.C., metropolitan area, its headquarters in Rockville, and several dispersed office buildings. The first building, the Life Sciences Laboratory, was completed and opened in December 2003, initially staffed by 104 employees. As of December 2018, the FDA campus employed 10,987 employees and occupied approximately 3.8 million square feet (350,000 square meters) of office and laboratory space across 10 office and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM).

according toUnder the 2017 FDA Reauthorization Act, the FDA projected a 64% increase in its workforce over the next 15 years, reaching 18,000 employees, and planned to add approximately 1.6 million square feet (150,000 square meters) of office and special-purpose space. In December 2018, the National Capital Planning Commission approved this expansion plan, with construction expected to be completed by 2035 with GSA funding.

On-site office location

Office of Regulatory Affairs

The Office of Regulatory Affairs is consideredThe "eyes and ears" of the FDA are responsible for most of the on-site work. Its employees are called consumer safety officers, commonly referred to as investigators, who are responsible for inspecting production and storage facilities, investigating complaints, disease outbreaks, etc., and reviewing relevant documents for products such as medical devices, drugs, and biological products that are difficult to physically inspect or sample. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 jurisdictions, which roughly correspond to the geographical divisions of the federal courts. Each jurisdiction has a main office area and multiple outposts, which are remote offices of the FDA that serve a specific geographical area. The Office of Regulatory Affairs also includes the agency's regulatory laboratory network, which is responsible for analyzing the physical samples collected. Although most of the samples are food, some laboratories have the ability to analyze drugs, cosmetics and radiation-emitting equipment.

Other locations

The FDA has multiple field offices throughout the United States, as well as international locations in China, India, Europe, the Middle East, and Latin America.

Scope of Responsibilities and Funding

As ofIn 2021, the FDA oversaw $2.7 trillion worth of food, medical, and tobacco products. 54% of its budget came from the federal government, while 46% came from industry user fees, such as those paid by pharmaceutical companies to expedite drug reviews. Forbes reported that pharmaceutical companies accounted for 75% of the FDA's drug review budget.

Regulatory Projects

Emergency Use Authorization (EUA)USA)

The Emergency Use Authorization mechanism is designed to facilitate the supply and use of medical countermeasures (including vaccines and personal protective equipment) during public health emergencies, such as the Zika virus, Ebola outbreaks, and the COVID-19 pandemic.

Regulations

Safety regulatory programs vary widely depending on the type of product, the potential risks, and the regulatory authority granted to the agency. For example,FDARegulates nearly every aspect of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety——However,FDARegulation of cosmetics primarily focuses on labeling and safety.FDAMost products are regulated through a set of published standards, which are enforced through a small number of facility inspections. Inspection observations are recorded in483On the table.

2018Year6moon,FDAreleased a statement containing new guidelines designed to help food and drug manufacturers“Implementing safeguards to prevent potential attacks on the U.S. food supply”One of the guidelines includes“intentional adulteration(IA)rule”, which requires the food industry to develop strategies and procedures to reduce the risk of compromise in highly vulnerable facilities and processes.

FDARegulatory shaming tactics are also used, primarily through online publication of non-compliance, warning letters, and“Shame List”Regulation through shaming exploits firms’ sensitivity to reputational damage. For example,2018In 2016, the agency published an online“blacklist”, which lists dozens of brand-name drug companies accused of using illegal or unethical tactics to try to block competition from generic drug companies.

FDAThey frequently collaborate with other federal agencies, including the Department of Agriculture, the Drug Enforcement Administration, Customs and Border Protection, and the Consumer Product Safety Commission. They also frequently work with local and state agencies on regulatory inspections and enforcement actions.

Food and dietary supplements

Food Safety Modernization Act (FSMA）

According to the latest data from the Centers for Disease Control and Prevention, approximately480010,000 people (per6philtrum1people) become sick from foodborne illnesses,12.810,000 people were hospitalized.3,000This represents a significant and largely preventable public health burden.

The U.S. Food and Drug Administration (FDAThe Food Safety Modernization Act (FSMA) is transforming the nation's food safety system, shifting the focus from responding to foodborne illnesses to preventing them. Congress passedFSMA, in response to dramatic changes in the global food system and our growing understanding of foodborne illness and its consequences, including the recognition that the prevention of foodborne illness is both a major public health issue and a threat to the economic health of the food system.

FDASeveral rules have been formulated to implementFSMA, recognizing that ensuring the safety of the food supply is a shared responsibility across multiple links in the global supply chain for human and animal food.FSMAThe rules clearly define the specific measures that must be taken at each stage to prevent pollution.

The U.S. Food and Drug Administration (FDA) Foods and dietary supplements are regulated by the United States Congress throughFDAUnder the Federal Food, Drug, and Cosmetic Act and its supporting regulations,FDAIt has the power to oversee the quality of food sold in the United States and monitor claims on food labels about ingredients and health benefits.

FDAThe food it regulates is broken down into various categories, including foods, food additives, added substances (artificial substances that are not intentionally added to food but end up in it), and dietary supplements. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids, and enzymes.FDAThe specific criteria adopted vary by category. In addition, legislation givesFDAA variety of tools are available to address violations of standards for specific substance categories.

according to1994The Dietary Supplement Health and Education Act of 1996DSHEA），FDAResponsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients comply with current requirements. These manufacturers and distributors may not advertise their products in a manner that misrepresents the product, and they are responsible for evaluating the safety and labeling of their products.[29]

FDAThere is one“Dietary Supplement Ingredient Advisory List”, which includes ingredients that are sometimes found in dietary supplements but require further evaluation. When an ingredient is excluded from use in dietary supplements, does not appear to be an approved food additive or recognized as safe, and/or is subject to premarket notification requirements but does not meet those requirements, the ingredient will be added to this list.

cosmetic

Under U.S. law, cosmetics and their ingredients do not need to obtain a license before they can be marketed.FDAApproval is required. The only exception is color additives (except for coloring materials used in coal tar hair dyes), which must be approved for their intended use. Companies and individuals selling cosmetics have a legal responsibility to ensure their products are safe. To take action on cosmetics on the market for safety reasons, we need reliable information demonstrating that the product poses a safety risk when used by consumers according to label instructions or customary usage.

The following resources are related to commonly asked questions about cosmetics. For information about cosmetic ingredients, see Cosmetic Ingredients.

Aromatherapy

Disposable wipes

Hair products (hair dyes, straighteners, removers, and cleaning products)

Makeup

nail products

Soaps & Lotions (Soap Manufacturer FAQs, Anti-Aging Products, Slimming Treatments, etc.)

Tanning products

Tattoos and permanent makeup

drug
The Center for Drug Evaluation and Research has established different requirements for three main categories of drugs: new drugs, generic drugs, and over-the-counter drugs. Drugs are considered to be manufactured by different manufacturers, use different excipients or inactive ingredients, are used for different purposes, or undergo significant changes.“New drugs”. For new molecular entities——Drugs that are not based on existing drugs——The requirements are the most stringent.

Medical countermeasures (MCMs）
Medical countermeasures (MCMs) refers to the ability to prevent or treat chemical, biological, radiological or nuclear (CBRN) Biological products and drugs that attack health effects.MCMsIt can also be used for the prevention and diagnosis ofCBRNSymptoms associated with aggression or threats. The U.S. Food and Drug Administration (FDA) runs a program called“FDAMedical Countermeasures Initiative”（MCMi) project, which is funded by the federal government and is intended to support relevant institutions and organizations in their efforts toMCMsPrepare for public health emergencies.

New drugs

New drugs are approved by the U.S. Food and Drug Administration (FDA) before being approved, they undergo a rigorous review process called a New Drug Application (NDA).NDA). In Donald·During President Trump's administration, the agency worked to expedite the drug approval process. However, critics sayFDAThe standards for the new drugs are not strict enough to prevent unsafe or ineffective drugs from being approved. By default, new drugs are available only with a prescription.OTC) state is an independent process, and the drug must first passNDAApproved. An approved drug is considered“Safe and effective when used as directed”Drugs produced by new manufacturers can be approved through two faster processes: Abbreviated New Drug Application (ANDA)YOU) or for complex generic drugs or biosimilars505(b)(2)Regulatory pathways.

In rare circumstances, compassionate use principles may allow for limited exceptions to the multi-step process involving animal testing and controlled clinical trials. 2015During the Ebola outbreak in 2009, theZMappThis is the case with and other experimental therapies that could be used to treat debilitating and/Exceptions may also be made for rare or very rare diseases with no satisfactory existing treatments or drugs, or for long periods without new drug development.IProgress toIIIThe program typically involves a gradual increase in the number of participants over several years and typically involves pharmaceutical companies, the government and its laboratories, and often medical schools, hospitals, and clinics. However, any exceptions to the above process are subject to strict review, inspection, and conditions, and are granted only after extensive research and at least some preliminary human trials have shown that they are considered somewhat safe and possibly effective. (SeeFDAaboutIIISpecial protocol evaluation for phase 2 trials.

FDAPost-marketing drug safety monitoring

Although clinical trials provide important information about the efficacy and safety of a drug, it is not possible to obtain complete information about the safety of a drug at the time of approval. Despite the rigorous steps of the drug development process, there are still limitations. Therefore, the true safety of a product actually becomes apparent gradually over the months or even years that the product is on the market.FDAReviews reports of problems with prescription and over-the-counter drugs and may decide to add warnings to dosage or usage information, as well as other actions for more serious problems.

Supplementary Application

If the developer wishes toNDAA supplemental application must be submitted for any major changes to the formulation, labeling, or dosage strength.FDAapproval.

Marketed drugsIN

If a sponsor wants to further develop an approved drug for a new use, dosage strength, new dosage form, or a different dosage form (e.g., an injection or oral solution as opposed to a tablet form), or if they want to conduct additional clinical studies or post-marketing safety studies, they will do so inINNext proceed.

Manufacturer inspection

FDAOfficials regularly inspect drug manufacturing facilities in the United States and, if approved products are manufactured overseas, also at foreign drug manufacturing facilities. Manufacturers may be notified of an inspection in advance, or the inspection may be unannounced. Inspections may be routine or prompted by specific issues or concerns. These inspections are designed to ensure that developers are following good manufacturing practices. If minimum standards are not met,FDAA factory can be closed.

pharmaceutical advertisements

FDARegulates prescription drug advertising and promotional labeling. The law prohibits developers from promoting their products for unapproved uses.

All advertising, such as product claims or reminders, must not be false or misleading. They must contain factual information about the drug's effectiveness, side effects, and prescribing information. These advertisements can be found in medical journals, newspapers and magazines, as well as on the Internet, television or radio.

Promotional labels differ from pharmaceutical advertisements in how they are distributed. Pharmaceutical companies distribute brochures or other promotional materials to doctors or consumers. Prescribing information for the drug must accompany the promotional labeling. For more information, visit Prescription Drug Advertising.

Generic drugs

New drugs are protected by patents when they are approved for marketing. This means that only the sponsor has the exclusive right to market the drug. Once a patent expires, other drug manufacturers can develop a generic version of the drug. Generic drugs are equivalent to brand-name drugs and must have the same:

· Dosage form

· strength

· Security

· quality

· Performance characteristics

· Intended Use

Because generic drugs are equivalent to medications already on the market, generic drug manufacturers do not have to conduct clinical trials to prove the safety and effectiveness of their products. Instead, they conduct bioequivalence studies and submit abbreviated new drug applications (YOUIf pharmaceutical companies want to obtain approval to produce generic drugs, the U.S. Food and Drug Administration (FDA) requires scientific evidence to prove that generic drugs are interchangeable or therapeutically equivalent to brand-name drugs. Currently, about 20% of prescription drugs sold in the United States are80%For generic drugs.

Report a Problem

FDASeveral programs allow manufacturers, health professionals, and consumers to report problems with approved drugs.

· MedWatchis a portal for reporting problems with medical products (drugs and medical devices) and for learning about new safety information. You can subscribe to regularMedWatchSecurity alert.

· Medical Product Safety Network (MedSun) Monitor the safety and effectiveness of medical devices.FDARecruited from across the United States350to your healthcare provider to report any medical device problems that result in serious injury or death.FDAPublished monthlyMedSunNewsletter. This newsletter provides consumers with important information about medical device safety.

Active monitoring

exist“Sentinel Project”Down,FDAA new national system is being developed to more quickly identify possible safety issues. The system will use very large existing electronic health databases.——such as electronic health record systems, administrative and insurance claims databases, and registries——to monitor the safety of approved medical products in real time.FDAExisting post-marketing safety assessment tools will be added to, but will not replace, them.“Sentinel Project”and information on its main activities.

Generic drugs（Generic drugs)

Generic drug scandal
1989In 2001, a major scandal broke out involving the U.S. Food and Drug Administration (FDA) The process for approving generic drugs for sale.1988In the year, the CongressFDAThe allegations of corruption in generic drug approvals first surfaced in a wide-ranging investigation by the U.S. House Energy and Commerce Committee's oversight subcommittee, based on a review of the Mylan Laboratories Inc.FDAMylan was found guilty ofFDARepeated delays, believing that they were discriminated against,1987Mylan ultimately sued two formerFDAemployees and four pharmaceutical companies, alleging corruption within the federal agency led to racketeering and antitrust violations. Mylan said,“The approval order for new generic drugs isFDAStaff are identified before the drugmaker submits its application”, this illegal program is designed to favor some companies over others.1989In the summer of 2011, threeFDAOfficer (Charles·AND·Zhang, David·J·Brancato, Walter·Klein, pleaded guilty to criminal charges of accepting bribes from generic drug manufacturers, and two companies (Pal Pharmaceuticals and its subsidiaries)QuadPharmaceuticals) also pleaded guilty to bribery.

In addition, it was found that several manufacturers were applying forFDAFalsified data were submitted during the approval process for certain generic drugs. New York-based Vitalin Pharmaceuticals applied for approval of a hypertension drug.DyazideWhen submitting the original drugDyazideconductFDAtest.1989Year4moon,FDAInvestigated11Irregularities of manufacturers, later increased to13Dozens of drugs were ultimately suspended or recalled.1990In the early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against Birla Pharmaceuticals, a major generic drug manufacturer based on Long Island, New York.

Over-the-counter medications

Over-the-counter medications(OTC)These are medications that don't require a prescription, like aspirin.(FDA)There is an approximate800 A list of 50 approved ingredients that can be combined in various ways to produce more than10 10,000 over-the-counter (OTC) drug products. Many OTC ingredients, such as ibuprofen, were previously prescription drugs and are now considered safe enough to use without the supervision of a healthcare practitioner.

“FDAApproved for marketing”and“FDAapprove”The difference

If medical devices are to be obtained“Approved for marketing”, it is necessary to prove that it is comparable to similar devices already on the market“Basically equivalent”.and“approve”It is applicable to products that are new or significantly different from existing devices and need to prove their“Safety and effectiveness”For example, its safety may be checked for new toxicological hazards. Both of these aspects require proof or documentation from the submitter to ensure that the correct procedures were followed.

Veterinary products

Veterinary Medicine Center (CVM) is the U.S. Food and Drug Administration (FDA) is a department within the U.S. Department of Agriculture that regulates food additives and drugs used on animals.CVMRegulate animal medicines, animal feed including pets, and animal medical devices.FDARequirements for preventing the spread of BSE are also provided byCVMThis is enforced through inspections of feed producers.CVMIt is not responsible for the regulation of animal vaccines, which is the responsibility of the U.S. Department of Agriculture.

tobacco products

The U.S. Food and Drug Administration (FDA)according to2009Family Smoking Prevention and Tobacco Control Act of 1996[77]The bill mandates the use of color warnings on cigarette packages and in print advertisements, as well as text warnings from the U.S. Surgeon General.[78]

FDAAt2011Year6Nine new graphic warning labels were announced in January and are scheduled for release in2012Year9months ago.R.J. Reynolds Tobacco Co. v. U.S. Food and Drug AdministrationLitigation in one case is still ongoing, so the implementation date is uncertain.[79] R.J. Reynolds、Lorillard、Commonwealth Brands、Liggett GroupandSanta Fe Natural Tobacco CompanyThe lawsuit, filed in federal court in Washington, D.C., claims that graphic labeling is an unconstitutional way to force tobacco companies to engage in anti-smoking advocacy on behalf of the government.[80]

A man named Freud·Abrams, a First Amendment attorney who represented tobacco companies in the case, argued that requiring graphic warning labels on legal products would not withstand constitutional scrutiny.[81] The Association of National Advertisers and the American Advertising Federation also filed a complaint arguing that the labels infringe on commercial free speech and, if left unchecked, could lead to further government intervention.[82] 2011Year11In July, Judge Richard·Lyon's temporary halt to the new labels could delay a requirement for tobacco companies to display them. The U.S. Supreme Court could ultimately rule on the matter.[83]

2017Year7moon,FDAAnnounced a plan to reduce the amount of nicotine currently permitted in tobacco cigarettes.[84] The proposed regulations, no.ALSO 0910-AI76, titled“Nicotine content standards for cigarettes and certain other combustible tobacco products”, which aims to reduce the nicotine content in cigarettes to about0.7mg.

Science and research projects

The U.S. Food and Drug Administration (FDA) conducts research and development activities to develop technologies and standards that support its regulatory functions, with the goal of addressing scientific and technological challenges before they become obstacles.FDAHer research interests include biologics, medical devices, pharmaceuticals, women's health, toxicology, food safety and applied nutrition, and veterinary medicine.[97]